Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma

• ClinicalTrials.gov Identifier: NCT00681473
• Recruitment Status: Completed
• First Posted: May 21, 2008
• Results First Posted: January 9, 2017
• Last Update Posted: March 7, 2017
• Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Helen A. Shih, MD, Massachusetts General Hospital

Study Description

Brief Summary:

In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.

Condition or disease	Intervention/treatment	Phase
Low Grade Gliomas	Radiation: Proton Radiation Therapy	Not Applicable

Detailed Description:

• Participants will receive radiation therapy for 6 weeks, given in daily doses, Monday through Friday, for a total of 30 treatments.
• A medical history and physical examination will be performed prior to the start of radiation treatment, weekly during the 6 weeks of radiation and after the finish of radiation performed at 3 and 6 months and then annually for 5 years.
• Hormonal function tests will be taken prior to the start of radiation treatment and after the finish of radiation treatment at 3 and 6 months, and annually for five years to assess the participants hormonal functions as they relate to the pituitary gland's function.
• A brain MRI will be performed prior to the start of radiation treatment and then performed at 3 and 6 months after radiation treatment then annually for 5 years.
• A neurocognitive exam will be performed prior to the start of radiation therapy, a limited exam 6 months after the completion of radiation therapy, and a complete exam annually for 5 years.
• Quality of Life and Emotional Well-Being Questionnaires will be done before radiation begins, 2 months after radiation treatment, 6 months after radiation treatment and then annually for 5 years.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
• Study Start Date: July 2007
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Proton Radiation Therapy; Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.	Radiation: Proton Radiation Therapy; Once daily, Monday through Friday, for 6 weeks.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Late Effects > 3 Months Post RT [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Percentage of Participants With Progression Free Survival [ Time Frame: At 1, 3, and 5 years ]
   Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
2. Percentage of Participants With Overall Survival [ Time Frame: At 1, 3, and 5 years ]
   Percentages were estimated by Kaplan Meier

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
• Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
• KPS of 70 or greater
• 18 years of age or older
• Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
• Must be able to speak and comprehend English

Exclusion Criteria:

• Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
• Prior history of cranial irradiation
• Pregnancy at the time of radiation treatment
• Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
• Comorbid illness or reason to suggest a life expectancy of less than 5 years

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Helen A. Shih, MD, MS, MPH; Massachusetts General Hospital

More Information

• Responsible Party: Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00681473
• Other Study ID Numbers: 06-195
• First Posted: May 21, 2008
• Results First Posted: January 9, 2017
• Last Update Posted: March 7, 2017
• Last Verified: January 2017

Keywords provided by Helen A. Shih, MD, Massachusetts General Hospital:

proton radiation therapy; photon radiation therapy

Additional relevant MeSH terms:

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue